1. Field of the Invention
The present invention relates generally to an electromechanical device for use with anastomosing, stapling, and resecting surgical tools, and more specifically to a electromechanical device by which surgical instruments such as anatomosing, stapling, and resecting tools may be remotely actuated.
2. Description of the Prior Art
Upon identification of cancerous or other anomalous tissue in the gastrointestinal tract, surgical intervention is often prescribed. The field of cancer surgery, and more specifically, the surgical procedure by which a section of the gastrointestinal tract which includes cancerous or anomalous tissue is resected, includes a number of uniquely designed instruments. In combination with a description of the present instrumentation and their functions, a description of the state of the art in this surgical procedure shall also be provided.
The first question which must be answered when determining how to treat gastrointestinal cancer relates to the specific location of the cancerous tissue. This is very important insofar as the instruments which are provided in the present art have limitations relating to how far they may be inserted into the gastrointestinal tract. If the cancerous tissue is too far up the colon, for example, then the standard instrumentation provided is unuseable, thus requiring special accomodations. These accomodations generally increase the risk of contamination of the surrounding tissues with bowel contents, increase the length of the surgery and the corresponding need for anaesthesia, and eliminate the benefits of precise anastomosing and stapling which comes from utilizing a mechanized device.
More specifically, in the event that the cancerous tissue is located at a position in the colon which is accessible by the present instrumentation, the patient""s abdomen is initially opened to expose the bowel. The surgeon then utilizes a linear cutter and stapling device which cuts the tube of the colon on either side of the cancerous tissue, thereby creating two stapled ends of the bowel (a distal end which is directed toward the anus, and the proximal end which is closest to the small intestine). This is done in order to temporarily minimize contamination.
More particularly, referring to FIG. 1, the bowel is placed between the scissoring elements 12,14 at the tip of the linear stapling instrument 10. By squeezing the trigger 16 in the handle 18 of the device, the surgeon causes the scissoring elements 12,14 to come together. A second trigger (or a secondary action of the same trigger) is then actuated to drive a series of staples 20 through the clamped end of the colon, thereby closing and transecting the ends.
The surgeon then partially opens the proximal end and inserts the removeable anvil portion of an anastomosing and stapling instrument into the exposed proximal end. This step, as well as those of the remainder of the surgical procedure, are related to the functioning of this surgical instrument. More particularly, and with respect to FIG. 2, the surgeon begins by taking the instrument 30 and manually turning the dial 32 at the base of the handle 34 which causes the anvil head 36 at the opposite end to advance forward. The surgeon continues to turn the dial 32 until the anvil head 36 advances to its most extreme extended position. This manual turning requires nearly thirty full rotations. Once fully extended, the anvil head of the instrument is decoupled therefrom and is inserted into the partial opening of the proximal end such that the coupling post extends outwardly therethrough. This partial opening of the proximal end is then sutured closed. The extending shaft 38 of the anastomosing and stapling intrument 30 is then inserted and advanced into the lower colon, transanally, until the coupling stem 40 thereof extends through the stapled distal end. The surgeon then joins the coupling ends of the anvil and shaft together and begins to manually rotate the dial in the handle again, this time bringing the anvil head closer to the end 42 of the shaft.
Once the anvil head and shaft are brought close together, after the surgeon has manually rotated the dial another thirty times, a grip-style trigger 44 in the handle is manually actuated. This actuation causes a circular blade 46 to advance axially out from the tip of the shaft, and into contact with the opposing face 48 of the anvil 36. The blade cuts through the stapled-closed ends of the proximal and distal ends of the colon, thereby also cutting a new pair of ends of the proximal and distal portions of the colon. The tissue which has been severed is held in an interior volume at the end of the shaft.
In lock step with the cutting, the freshly opened ends are joined together by a series of staples 50 which are advanced through holes in the perimeter of the tip of the shaft (being pressed against and closed by the opposing face of the anvil). The coupled shaft and anvil are then withdrawn from the patient.
More particularly with respect to the structural features of the linear stapling instrument 10 of the prior art which is provided in FIG. 1, the device comprises a pistol grip-styled structure 18 having an elongate shaft 19 and distal portion 20. The distal portion includes a pair of scissor-styled gripping elements 12,14 which clamp the open ends of the colon closed. In fact only one of the two scisor-styled gripping elements, the upper jaw portion 12, moves (pivots) relative to overall structure; the other remains fixed. The actuation of this scissoring means (the pivoting of the upper jaw 12 portion) is controlled by means of a grip trigger 16 maintained in the handle. A number of different means have been disclosed for holding the tips of the scissoring arms closed, including snaps, clips, collars, et al.
In addition to the scissoring means, the distal portion also includes a stapling mechanism. The non-moving lower jaw 14 of the scissoring mechanism includes a staple cartridge receiving region and a mechanism for driving the staples 20 up through the clamped end of the colon, against the upper jaw portion, thereby sealing the previously opened end. The scissoring elements may be integrally formed with the shaft, or may be detachable such that various scissoring and stapling elements may be interchangeable.
More particularly with respect to the structural features of the anastomosing and stapling instrument of the prior art which is provided in FIG. 2, the device comprises an anvil portion 36, a staple, blade and reservior portion 42, a shaft portion 38, and a handle portion 34. The anvil portion 36, which is selectively removeable from the tip of the shaft, is bullet shaped, having a blunt nosed top portion, a flat cutting support surface 48 on the bottom, and a coupling post 41 extending axially from the bottom surface.
The staple, blade, and reservior portion 42 (SBR portion) of the instrument is provided at the distal end of the instrument, and includes a selectively advanceable and retractable coupling stem 40 for selectively receiving thereon the anvil portion. This action of the coupling stem is provided by a screw threaded shaft and worming mechanism mounted in the handle 34 (described more fully below). The SBR portion is cylindrical in shape, forming a housing which has a hollow interior. It is this hollow interior which forms the reservior 47. The blade 46 is similarly cylindrical, and seats in the inside of the housing, against the inner wall thereof. The blade is selectively advanceable axially outward from the housing, in accordance with actuation of a trigger 44 mechanism of the handle (again, described more fully below). On the axially outward facing surface of the cylindrical wall of the housing are a series of staple ports, through which the staples 50 of the device are discharged. The same actuation which drives the blade forward similarly drives a series of staple drivers forward within the cylindrical walls. More accurately, the staple driver is a cylindrical component which has a series of protuberances on the axial end thereof, the protuberances being positioned in accordance with the distribution of staples and holes. The staples, prior to being discharged, are mounted in the holes; and they are advanced through the holes by the action of the staple driver and the protuberances thereof.
The shaft portion 38 of the instrument is a simple rigid extended structure which is intended as a sheath for a pair of elongate rods. The first rod is coupled to the worming mechanism introduced above, and described more fully below with respect to the handle portion, and is the means by which the anvil portion and the coupling stem of the SBR portion are selectively advanced and retracted. The second rod is coupled to the trigger 44 of the handle at one end (also introduced above, and described more fully below) and to the blade 46 and staple driver 45 at the other end. The sheath protects the patient and the instrument when it is advanced into the colon transanally. The nature of the actuation mechanisms however, requires that the shaft be rigid. This rigidity limits the length of the shaft 38; and combination, i.e. the length and rigidity of the instrument, these features limit the sections of the colon which may be treated using this device.
The handle 34 of this instrument of the prior art comprises a pistol grip styled structure having a turning dial 32 at the butt (i.e. the end opposing the junction of the shaft portion which the handle) and a finger actuated trigger 44. The trigger includes a safety mechanism which physically prevents actuation unless moved out of the interference position. The turning dial 32 is actionably coupled to a worming mechanism which is used to advance the first rod of the shaft portion (thereby advancing the coupling stem and the anvil 36). The trigger functions as a basic lever to push the second rod forward within the shaft, thereby advancing the blade 46 and staple driver 45.
As with many such devices of the prior art, all of these devices are considered fully disposable, and are, in fact, thrown away after a single use. They are complicated devices, haing multiple moving parts, requiring substantial structural integrity and, therefore, expense in manufacturing. The fact that they are used only once, and no part can be used again render the use of such devices expensive and wasteful of resources.
In addition to this failure, as can be readily observed from the preceeding descriptions, the prior art devices suffer from numerous other limitations which would be desirable to overcome. These include the rigid and limited length shaft of the anastomosing and stapling instrument (which limits the portion of the gastrointestinal tract which may be treated by such a device), as well as the requirement that the surgeon manually actuate a number of different functions (including those associated with the dial and trigger of the anastomosing and stapling instrument and the multiple triggers of the cutting and stapling instrument).
Therefore, it is a principal object of the present invention to provide an instrument for cutting, anastomosing, and stapling, for use in gastrointestinal surgery, which reduces the waste of resources by permitting the reuse of portions thereof.
It is also a principal object of the present invention to provide an instrument which increases the region of the gastrointestinal tract for which it may be used.
It is correspondingly an object of the present invention to provide a gastrointestinal tract surgery instrument assembly which has a flexible shaft component.
It is further an object of the present invention to provide an instrument assembly which reduces the requirements for the surgeon to manually actuate different components and mechanisms.
Other objects of the present invention shall be recognized in accordance with the description thereof provided hereinbelow, and in the Detailed Description of Preferred Embodiments in conjunction with the remaining Figures.
The preceeding objects of the invention are provided by an electromechanical driver assembly which couples and actuates both a linear stapling attachment and an anastomosing and stapling attachment. It may be recognized by the astute reader that both of the instruments of the prior art, which have been described above, have similar dual actions. More particularly, the linear stapling instrument first clamps and then staples, and the anastomosing and stapling instrument advances and retracts an anvil portion, which is, in effect, a clamping action, and then drives a blade and staples forward. It is, therefore, possible to construct a single common driver assembly which can be used to actuate the functions of each, such that the differing functions may be specific only to attachments, and not to the entirety of the instrument.
More particularly, the present invention comprises three components, which are (1) an electromechanical driver, (2) a linear clamping and stapling attachment, and (3) an anastomosing and stapling attachment, the latter two attachments having a common designed coupling interface which joins with the driver component. It is, however, anticipated that other attachments will be used as well.
First, with respect to the electromechanical driver, the driver has a handle and a flexible drive shaft. The handle has a pistol grip-styled design, having one or more, and preferably two, finger triggers which are independently coupled to at least one, and preferably two separate motors which each turn separate flexible drive shafts (described more fully, hereinbelow). The motors are each dual direction motors, and are coupled to a manual drive switch mounted to the top of the handle, by which the user can selectively alter the turning direction of each motor. This dual direction capacity may be most simply achieved by selecting motors which turn in a direction corresponding to the direction of current, and actuation of the drive switches alters the direction of the current accordingly. In this example, the power source supplying the motors must be a direct current source, such as a battery pack (and most desireably, a rechargeable battery pack). In the event that the device should be useable with an alternating current, either a transformer can be included, or a more sophisticated intermediate gearing assembly may be provided. In conjunction with the present description, the embodiments of the present invention which will be described utilize a rechargeable battery pack providing a direct current.
In addition to the motor components, the handle further includes several other features, including: (1) an remote status indicator; (2) a shaft steering means; and (3) at least one additional electrical supply. First, the remote status indicator may comprise an LCD (or similar read out device) by which the user may gain knowledge of the position of components (for example whether a clamping element is in the proper position prior to the driving of the staples). Second, the handle also includes a manually actuateable steering means, for example, a joystick or track ball, for directing the movement of the flexible shaft (by means of guidewires implanted in the shaft portion described more fully hereinbelow). Finally, the handle may include an additional electrical power supply and an on off switch for selectively supplying electrical power to the attachments.
More particularly, with respect to the flexible shaft, the shaft comprises a tubular sheath, preferably formed of a simple elastomeric material which is tissue compatible and which is sterilizable (i.e. is sufficiently rugged to withstand an autoclave). Various lengths of this shaft may be provided in conjunction with the present invention. In this case, the flexible shaft and the handle portions should be separable. If separable, the interface between the proximal end of the shaft and the distal end of the handle should include a coupling means for the drive components.
Specifically regarding the drive components of the shaft, within the elastomeric sheath are a pair of smaller fixed tubes which each contain a flexible drive shaft which is capable of rotating within the tube. The flexible drive shaft, itself, simply must be capable of translating a torque from the motor in the handle to the distal end of the shaft, while still being flexible enough to be bent, angled, curved, etc. as the surgeon deems necessary to xe2x80x9csnakexe2x80x9d through the colon of the patient. For example, the drive shafts may comprise a woven steel fiber cable. It shall be recognized that other drive shafts may be suitable for this purpose. In order for the distal end of the drive shaft to couple with an attachment, such as the clamping and stapling device of the present invention (as described more fully below), however, the distal tips of the drive shafts must have a conformation which permits the continued translation of torque. For example, the distal tips of the drive shafts may be hexagonal, thereby fitting into a hexagonal recess in the coupling interface of the attachment. Appropriate gearing mechanisms may be provided at the distal end of the shaft, or in the interfacing portion of the attachment, to ensure that the appropriate torque is provided to the attachment.
As suggested above, in conjunction with the manually actuateable steering means mounted to the handle, the sheath further includes at least two guidewires which are flexible, but are coupled to the inner surface of the sheath near the distal end thereof. The guidewires may be axially translated relative to one another by actuation of the steering means, which action causes the sheath to bend and curve accordingly.
Also as suggested above, in conjunction with the LCD indicator of the handle, the shaft further contains an electrical lead for coupling to the attachments. This electrical lead channels a signal from the attachment to the handle for indicating the status of the attachment (for example, whether a clamping function is holding). Similarly, a second electrical lead may be provided to supply power to separate aspects of the attachment if so required (for example, as will be described more fully with respect to one embodiment of the linear stapling attachment, the use of selectively engageable electromagnetic seal for ensuring continued clamping through the stapling process may be provided and require power selectively provided from the handle""s power supply.
More particularly, with respect to the linear clamping and stapling attachment, which has several different potential embodiments, two of which are disclosed herein as examples, the attachment is fitted with two drive extensions, which in operation function as extensions of the flexible drive shafts of the electromechanical driver. That is, when the attachment is mated to the electromechanical driver, the drive extensions are in mechanical communication with the flexible drive shafts such that the activation of the drive shaft motors activates the drive extensions within the linear clamping and stapling attachment. In each embodiment of the attachment, the first drive extension enables a linear clamping mechanism, while the second drive extension enables a stapling mechanism. In one embodiment, the linear clamping mechanism comprises a scissors-cuff system whereby the pivoting upper jaw of the scissors is clamped to the fixed lower jaw of the scissors as a cuff enclosing a length of the scissors is moved from the hinged end of the scissors toward the closing end of the scissors. The scissors can be unclamped as the cuff is returned to its original position. In this embodiment, the first drive extension moves the cuff forward or backward, depending on the turning direction of the corresponding motor in the electromechanical driver.
In a second embodiment, the linear clamping mechanism comprises a separating jaw system whereby an upper jaw is raised and subsequently lowered to meet a lower jaw to effect a clamping. In this embodiment, the first drive extension engages a pair of threaded vertical shafts which raise or lower the upper jaw depending on the turning direction of the corresponding motor in the electromechanical driver.
In each of these embodiments, the stapling mechanism comprises a replaceable tray of open staples set within the lower jaw and a set of corresponding staple guides fitted on the upper jaw, such that when the linear clamping mechanism is in a closed position, the open staples immediately oppose the corresponding staple guides. The stapling mechanism further comprises a wedge pushing system whereby once the linear clamping mechanism is in a closed position, a wedge riding in a channel below the tray of open staples is pushed through the channel. As the wedge moves through the channel, a sloping surface of the wedge pushes the open staples against the corresponding staple guides, thereby closing the staples. After the staples have been closed, the wedge is pulled back through the channel. The second drive extension pushes or pulls the wedge through the channel, depending on the turning direction of the corresponding motor in the electromechanical driver, by engaging a threaded horizontal shaft upon which the wedge, having a matching inner thread, rides.
The distal ends of the scissoring or linearly closing jaws may further include an electromagnetic securing mechanism which serves to hold the distal tips of the jaws together during the stapling step. This is preferred insofar as the action of driving the staples upwardly against the staple guides of the upper jaw may serve to open the jaws. In addition, the electromagnetic securing mechanism may be coupled in electrical communication with the LCD indicator mechanism in the handle (described above) such that the surgeon operating the device may be made aware of when the jaws have closed and the device is in a safe stapledriving position.
Referring now to the anastomosing and stapling attachment, a preferred embodiment is described hereinbelow as a single example of the different variations which could be constructed for the equivalent purpose. As with the linear stapling attachments described above, however, this example demonstrates the universal applicability of the overall electromechanical driver mechanism of the present invention. This attachment comprises an anvil portion, and a staple, blade and reservior portion, which includes a pair of turning drive shafts which are coupleable to the drive components of the shaft element described above, and a corresponding pair of advancing and retracting nuts mounted to the turning drive shafts, but which are prevented from rotating and therefore linearly advance and retract along the shafts when they turn.
The anvil portion includes is bullet shaped, having a blunt nosed top portion, a flat cutting support surface on the bottom, and a freely rotating coupling post extending axially from the bottom surface. This coupling post is designed to be selectively coupleable and removeable from the corresponding nut mounted to one of the turning drive shafts.
The staple, blade, and reservior portion (SBR portion) is cylindrical in shape, forming a housing which has a hollow interior. It is this hollow interior which forms the reservior. On the axially outward facing surface of the cylindrical wall of the housing are a series of staple ports, through which the staples of the device are discharged. A series of staple drivers are mounted within the cylindrical walls, beneath the staple ports, for driving the staples therethrough. More accurately, the staple drivers are a series of protuberances on the outer edge of a single cylindrical component which seats in the wall of the SBR portion. The staples, prior to being discharged, are mounted in the holes; and they are advanced through the holes by the forward motion of the staple driver and the protuberances thereof. The blade is similarly cylindrical, and seats in the inside of the housing, against the inner surface of the wall thereof. Both the blade and the staple driver are mounted to the second nut, which is, in turn, mounted to the other turning drive shaft. As the tuning drive shaft rotates, the nut (which is constrained against rotating) advances along the shaft, thus linearly advancing the blade and staple driver. The blade and the staple driver are, therefore, selectively advanceable axially outward from the housing, in accordance with actuation of the appropriate trigger on the handle.
In a preferred embodiment, the anvil portion and the SBR portion further comprise an electromagnetic sensor mechanism, coupled to the LCD indicator of the handle, which sensor is activated when the two portions have approached each other to the extent necessary for a safe staple firing, whereby the surgeon may have remote knowledge of the state of the attachment disposed within the colon.
In practice, this attachment is utilized, once the section of the colon which is to be removed has been resected (but prior to the linear clamping and stapling step is complete), in the following manner. The surgeon begins by coupling the anastomosing and stapling attachment to the electromechanical driver and advancing the anvil portion to its fullest extent. The anvil head is then removed and inserted into the partially opened proximal end. As described above, this proximal end is then sutured closed. The sugeon then advances the shaft and the SBR portion of the attachment up the colon until it extends through the stapled distal end of the colon. The surgeon then couples the anvil to the advancing and retracting nut of the corresponding drive shaft. Subsequent triggering of the motor in the handle causes the anvil to retract toward the SBR portion. As stated above, in a preferred embodiment, the base of the anvil and the outer edge of the SBR housing comprise an electromagnetic sensor which is coupled to the LCD indicator of the handle, thereby permitting the surgeon to know when the anvil and the SBR have come close enough to drive the blade and staples. Subsequent actuation of the other trigger on the handle causes the corresponding other turning drive shaft to advance the blade and staple driver into contact with the opposing face of the anvil. The blade cuts through the stapled-closed ends of the colon, leaving the tissue which has been severed in the interior reservior. Simultaneous with the cutting, the freshly opened ends are joined together by the series of staples which are advanced through holes in the perimeter edge of the SBR (being pressed against and closed by the opposing face of the anvil). The attachment and the flexible shaft are then withdrawn from the patient.